AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC— 510(k) K972550

Name: FDA 510(k) clearance K972550
Creator: U.S. Food and Drug Administration
Published: 1997-07-31

Substantially Equivalent

Trutone

FDA 510(k) clearance K972550 for AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC, Substantially Equivalent on 1997-07-31. Applicant: Trutone. Device class: 1.

Clearance details

Applicant: Trutone
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1997-06-30
Decision date: 1997-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.